PALETTE - Adaptive platform trial for personalisation of sepsis treatment in children and adults: a multi-national, treatable traits-guided, adaptive, exploratory, bayesian basket trial

Condition studied

Sepsis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Dual primary endpoints will be 1/ 28-day all-cause mortality 2/ Number of days alive without life-supportive therapies (respiratory support: high flow oxygen, non-invasive or invasive mechanical ventilation, extracorporeal membrane oxygenation or CO2 removal; cardiovascular support: continuous infusion of any dose of vasopressor or inotrope, or mechanical circulatory assistance; renal support: intermittent or continuous renal replacement therapy) at day 28 after randomization

Endpoint detail

Composite and hierarchised of the 2 dual primary outcomes, using a Generalized Pairwise Comparison (GPC) for Prioritized Outcomes,, 90-day, 1-year, and 3-year survival, 1- and 3-years hospital free days, Time to recover walking without aid, Time to resume previous social and professional activities, Quality of life at 90-day, 1-year, and 3-year using, in adults, SF-36, and 5-level EQ-5D version (EQ-5D-5L), and in children the Functional Status Scale (FSS) and the PedsQL.